FLUCLOXACILLIN 500 MG CAPSULES

Transcript

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUCLOXACILLIN 250MG CAPSULES
FLUCLOXACILLIN 500MG CAPSULES
(Flucloxacillin)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their signs of illness are
same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Flucloxacillin Capsules are and what are they
used for
2. What do you need to know before you take
Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Contents of the pack and other information

1. What Flucloxacillin Capsules are and
what are they used for
The name of the medicine is Flucloxacillin 250mg or 500mg
Capsules which will be referred to as Flucloxacillin Capsules
throughout this leaflet.
The active ingredient is flucloxacillin.
Flucloxacillin belongs to a group of medicines called Beta-lactamase
resistant penicillins. It is an antibiotic used to treat infections by
killing the bacteria that cause them.
Flucloxacillin is used to treat the following infections in adults, and
children aged 2-10 years. It can also be used in children less than
2 years of age. Your doctor will adjust the dose depending on the
age of the patient
• skin and soft tissue infections (including boils, abcesses,
carbuncles, ulcers, infected eczema and acne, wounds

2. What you need to know before you take Flucloxacillin
Capsules
Do not take Flucloxacillin Capsules if you:
• have ever been told you are allergic to flucloxacillin, any other
antibiotics (especially penicillin) or any other ingredients (these
are listed in Section 6.)
• have a previous history of jaundice (yellowing of the skin) or
liver problems related to flucloxacillin
Warnings and Precautions:
Tell your doctor before taking Flucloxacillin Capsules if you have
or have had any medical conditions, and especially if you:
• have had a skin rash, swelling of the face or neck, or any
serious complaint when taking any antibiotic
• are 50 years of age or older
• are suffering from any serious illness
• have liver problems
• are on a low-sodium diet
• are being treated for kidney problems or gout
• are taking this medicine for a long time as regular tests of liver
and kidney function is advised.
New-borns receiving flucloxacillin treatment should be regularly
monitored by the doctor.
Tell your doctor that you are taking Flucloxacillin if you are having
urine tests or blood tests because Flucloxacillin may affect the
results.
Other medicines and Flucloxacillin Capsules

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Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, or might take any other medicines.
This is because Flucloxacillin Capsules can affect the way some
medicines work. Also some other medicines can affect the way
Flucloxacillin Capsules work.
Especially:
• probenecid or sulfinpyrazone (to treat gout)
• methotrexate (a chemotherapy drug)
• oral typhoid vaccine (antibiotics can make it less effective)
• sugammadex (used with general anaesthetics)
• piperacillin (an antibiotic taken by injection)
• warfarin (medicine to prevent blood clotting)
Pregnant, breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist
for advise before taking this medicine.
Flucloxacillin capsules contain Sodium and Benzoates
Each 250mg capsule contains approximately 13mg of sodium
and each 500mg capsule contains approximately 25mg of sodium.
Check with your doctor before taking this medicine if you are on
a sodium restricted diet.
This medicine also contains methyl hydroxy benzoate and propyl
hydroxy benzoate which may cause allergic reactions.

3. How to take Flucloxacillin Capsules
• Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
• The dosage and duration of treatment will depend on the type
and severity of the infection.
• Take each capsule with a full glass of water
• Take this medicine when your stomach is empty. This means
an hour before food or 2 hours after food. It is important that you
take your medicine at the right times.
Adults:
• The usual dose is one 250 mg capsule four times a day.
• The dose may be doubled in case of severe infections.
• For infections of the joints (osteomyelitis) or heart (endocarditis),
the usual dose is up to 8 g daily in divided doses six to eight
hourly.
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4. Possible side effects
Like all medicines, this medicine cause side effects, although not
everybody gets them.
STOP TAKING this medicine and tell your doctor immediately if
you suffer from any of the following:

6. Contents of the pack and other information
What Flucloxacillin Capsules contain:
• The active ingredient is flucloxacillin (as flucloxacillin sodium).
• Flucloxacillin Capsules come in two strengths, 250mg and
500mg. Each capsule contains either 250mg or 500mg of the
active ingredient.
• The other ingredients are magnesium stearate, gelatin, indigo
carmine (E132), titanium dioxide (E171), shellac, methyl
hydroxybenzoate and propyl hydroxybenzoate.
What Flucloxacillin Capsules look like and contents of the
pack:
• The 250 mg capsules are blue coloured printed with “F 250”.
• The 500 mg capsules are blue coloured printed with “F 500”.
• The capsules are supplied to the pharmacist in packs containing
28 and 56 capsules; your pharmacist will provide you with the
required number of capsules as prescribed by your doctor.
• Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk
Flucloxacillin 250mg Capsules: PL 17907/0052
Flucloxacillin 500mg Capsules: PL 17907/0053
This leaflet was last revised in August 2015
To request a copy of this leaflet in Braille, large print or audio
format, please contact the licence holder at the address (or telephone,
fax, email) above.

5. How to store Flucloxacillin Capsules
• Keep this medicine out of the sight and reach of children.
• Blisters : Do not store above 250C. Store in the original packing.

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• Do not use this medicine after the expiry date shown on the
pack.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the enviroment.

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• hypersensitivity or severe allergic reaction including swollen
face or breathing problems. An unexpected skin reaction,
e.g. a rash and/or a sore mouth or eyes
• blisters or ulcers (Stevens-Johnson syndrome)
• peeling and swelling of the skin that resembles burns (toxic
epidermal necrolysis)
• allergic skin reactions e.g. ‘hives’ or ‘nettle’ rash
• severe diarrhoea with bleeding
• notice your urine becoming darker or your faeces (otherwise
known as poo) becoming paler
• hepatitis (inflammation of the liver)
• cholestatic jaundice (skin or white of your eyes turning yellow)
• changes in numbers of blood cells (causing unexplained
bleeding, bruising or skin discolouration)
• inflammation of the kidney (nephritis), bowel and/or liver
• joint or muscle pain, this may develop after 2 days or more
from the start of treatment with Flucloxacillin
• fever, this may develop after two days or more from the start
of treatment with flucloxacillin
Common side effects: (effects less than 1 in 10 people but more
than 1 in 100 people)
• diarrhoea, stomach upset and feeling sick - should be mild and
wear off after a few days.
Very rare side effects: (effects less than 1 in 10,000 people)
• difficulty passing water or blood in urine (may be a sign of
inflammation of kidney)
Inflammation of kidney (interstitial nephritis) is usually reversible
when treatment is discontinued, but in rare situations can lead to
kidney failure
Some of these reactions can be delayed for up to two
months after finishing the treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this
medicine.

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• For surgical prophylaxis, 1 to 2g is given intravenously at
induction of anaesthesia followed by 500mg every six hours
for upto 72 hours.
Use in children:
• The usual dose for children aged 2-10 years is half the adult
dose.
• The dose for children under 2 years old is quarter of the adult
dose.
• Your doctor may prescribe a different dose depending on the
age, weight and severity of infection.
• If a dose of less than 250mg is required your doctor will
prescribe flucloxacillin in a dosage form that is suitable for
your needs.
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you
lower or fewer doses.
If you take more Flucloxacillin Capsules than you should
It is important to stick to the dose on the label. Taking more than this
can make you ill.
If you accidently take too many capsules, tell your doctor
immediately or contact your nearest Hospital Casualty/Accident
and Emergency Department even if there are no signs of discomfort.
Take your medicine in its original packaging with you in order to
enable the doctor to identify your medication easily.
If you forget to take Flucloxacillin Capsules
If you forget to take a dose, take it as soon as you remember,
however, if it is almost time for your next dose then, skip the
missed dose and then take your next dose when it is due.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE
FORGOTTEN DOSE
If you stop taking Flucloxacillin Capsules
Take all the capsules that have been prescribed for you, even if
you start to feel better. Your symptoms may start to improve
before the infection is completely treated. If you stop taking the
capsules too soon, your symptoms may return.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.